Label: SODIUM BICARBONATE ANTACID- sodium bicarbonate powder
Contains inactivated NDC Code(s)
NDC Code(s): 53145-390-04, 53145-390-08, 53145-390-16
- Packager: Menper Distributors Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated October 24, 2017
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
FOR ORAL USE ONLY
STOMACH WARNING: TO AVOID SERIOUS INJURY, DO NOT TAKE UNTIL POWDER IS COMPLETELY DISSOLVED. IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FILL FROM FOOD OR DRINK.
Do not use in children under 12 years of age.
Ask a doctor or pharmacist before use if you have a sodium-restricted diet.
Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.
Stop use and ask a doctor if
- you have used the maximum dosage for 2 wekks
- sever stomach pain occurs after using this product
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
- Take 1/2 teaspoon in 1/2 glass (4 fl. oz.) of water every 2 hours up to a maximum dosage or as directed by a doctor. Dissolve completely in water before drinking.
Age Maximum Dosage Adults 60 years and over Do not exceed three doses of 1/2 teaspoon in a 24 hour period Adults and children 12 years of age and over Do not exceed six doses of 1/2 teaspoon in a 24 hour period Children under 12 years Do not use
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
SODIUM BICARBONATE ANTACID
sodium bicarbonate powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53145-390 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE 2.616 g in 2.616 g Inactive Ingredients Ingredient Name Strength SODIUM CATION (UNII: LYR4M0NH37) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53145-390-16 454 g in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2017 2 NDC:53145-390-08 227 g in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2017 3 NDC:53145-390-04 113 g in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 01/01/2017 Labeler - Menper Distributors Inc. (101947166)